- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452685
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
May 7, 2014 updated by: Takeda
A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis
The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).
Study Type
Interventional
Enrollment (Actual)
397
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Nagoya-shi, Aichi, Japan
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Chiba
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Chiba-shi, Chiba, Japan
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Funabashi-shi, Chiba, Japan
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Ichihara-shi, Chiba, Japan
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Yachiyo-shi, Chiba, Japan
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Ehime
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Nihama-shi, Ehime, Japan
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Fukui
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Fukui-shi, Fukui, Japan
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan
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Iizuka-shi, Fukuoka, Japan
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Kitakyushu-shi, Fukuoka, Japan
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Onga-gun, Fukuoka, Japan
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Yanagawa-shi, Fukuoka, Japan
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Fukushima
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Koriyama-shi, Fukushima, Japan
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Gifu
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Takayama-shi, Gifu, Japan
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Gunma
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Takasaki-shi, Gunma, Japan
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Hirosima
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Hirosima-shi, Hirosima, Japan
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Hokkaido
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Ebetsu-shi, Hokkaido, Japan
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Ishikari-shi, Hokkaido, Japan
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Sapporo-shi, Hokkaido, Japan
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Hyogo
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Amagasaki-shi, Hyogo, Japan
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Kako-gun, Hyogo, Japan
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Kawanishi-shi, Hyogo, Japan
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Kobe-shi, Hyogo, Japan
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Ishikawa
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Kanazawa-shi, Ishikawa, Japan
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Kagawa
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Marugame-shi, Kagawa, Japan
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan
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Kanagawa
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Hiratsuka-shi, Kanagawa, Japan
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Kamakura-shi, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yamato-shi, Kanagawa, Japan
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Yokohama-shi, Kanagawa, Japan
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Kochi
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Nankoku-shi, Kochi, Japan
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan
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Kyoto
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Kyoto-shi, Kyoto, Japan
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Miyagi
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Sendai-shi, Miyagi, Japan
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Nagano
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Matsumoto-shi, Nagano, Japan
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Nagano-shi, Nagano, Japan
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Suzaka-shi, Nagano, Japan
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Nara
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Nara-shi, Nara, Japan
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Oita
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Oita-shi, Oita, Japan
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Okayama
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Kurashiki-shi, Okayama, Japan
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Okayama-shi, Okayama, Japan
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Osaka
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Hirakata-shi, Osaka, Japan
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Ibaraki-shi, Osaka, Japan
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Ikeda-shi, Osaka, Japan
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Osaka-shi, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Suita-shi, Osaka, Japan
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Tondabayashi-shi, Osaka, Japan
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Toyonaka-shi, Osaka, Japan
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Saitama
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Iruma-shi, Saitama, Japan
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Shiga
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Kusatsu-shi, Shiga, Japan
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Shizuoka
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Hamamatsu-shi, Shizuoka, Japan
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Numazu-shi, Shizuoka, Japan
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Yaizu-shi, Shizuoka, Japan
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Tokushima
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Komatsushima-shi, Tokushima, Japan
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Naruto-shi, Tokushima, Japan
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Tokyo
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Bunkyo-ku, Tokyo, Japan
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Chiyoda-ku, Tokyo, Japan
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Chuo-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Machida-shi, Tokyo, Japan
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Minato-ku, Tokyo, Japan
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Ohta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Suginami-ku, Tokyo, Japan
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Toyama
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Toyama-shi, Toyama, Japan
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Yamaguchi
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Yamaguchi-shi, Yamaguchi, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
1. Participants who have completed TAK-385/CCT-101 study
Exclusion Criteria:
- Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult
- Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings
- Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk
- Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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EXPERIMENTAL: TAK-385 10 mg QD
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TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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EXPERIMENTAL: TAK-385 20 mg QD
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TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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EXPERIMENTAL: TAK-385 40 mg QD
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TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
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OTHER: Leuplin
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TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Mineral Density
Time Frame: Up to Week 24.
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Measured by Dual-energy X-ray absorptiometry (DXA)
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Up to Week 24.
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Treatment-emergent Adverse Events
Time Frame: Up to Week 16
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Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
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Up to Week 16
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Vital Signs
Time Frame: Up to Week 24
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Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
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Up to Week 24
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Body Weight
Time Frame: Up to Week 24
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Up to Week 24
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Electrocardiograms
Time Frame: Up to Week 24.
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Up to Week 24.
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Laboratory Values
Time Frame: Up to Week 24
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Up to Week 24
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Serum NTx
Time Frame: Up to Week 24
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NTx is one of the biochemical bone metabolism markers
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Up to Week 24
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Serum BAP
Time Frame: Up to Week 24
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BAP is one of the biochemical bone metabolism markers
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Up to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS) Score for Pelvic Pain
Time Frame: Up to Week 24
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Pelvic pain will be assessed using the VAS as pain evaluation scale
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Up to Week 24
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VAS Score for Dyspareunia
Time Frame: Up to Week 24
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Dyspareunia will be assessed using the VAS as pain evaluation scale
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Up to Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
August 31, 2011
First Submitted That Met QC Criteria
October 12, 2011
First Posted (ESTIMATE)
October 17, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 8, 2014
Last Update Submitted That Met QC Criteria
May 7, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-385/OCT-101
- U1111-1123-6973 (REGISTRY: WHO)
- JapicCTI-11589 (REGISTRY: JapicCTI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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